Weekly Update for the Week Ending December 21, 2019

Regulatory Update

The FDA approved for lemborexant (Dayvigo, Eisai) on 12/23/19 for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

The FDA approved for lumateperone (Caplyta, Intra-Cellular Therapies) on 12/23/19 for the treatment of schizophrenia in adults. Lumateperone has a boxed warning due to an increased risk of death for elderly patients with dementia-related psychosis. The label also contains a warning for increased risk for cerebrovascular events in this population.

The FDA approved ubrogepant (Ubrelvy, Allergan) on 12/23/19 for the acute treatment of migraine with or without aura in adults.

Announced Research Updates

Shanghai Green Valley Pharmaceutical plans to initiate an 18-month, 2,046 patient, Phase III trial in the U.S. and Europe in 2020 that will evaluate oligomannate in the treatment of mild-to-moderate Alzheimer's disease. Results were announced in the fall of 2019 from a 9-month trial, which found oligomannate slowed the decrease in the ADAS-Cog12 Score compared to placebo. While researchers were skeptical due to the short duration of the trial and lack of details, the results led to conditional approval in China. The new trial is being undertaken to answer questions about the drug from the FDA and EMA.

Published Research Updates

In a 312 patient, Phase III trial,  pixantrone/rituximab did not improve progression free survival compared to gemcitabine/rituximab in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after ≥1 rituximab-containing regimen and were not eligible for a stem cell transplant.

The World Health Organization recommended fexinidazole as a first-line treatment option for human African trypanosomiasis. The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) recommended approval of fexinidazole for the treatment of human African trypanosomiasis (HAT), more commonly known as sleeping sickness. CHMP gave the opinion under Article 58, which is designed to provide guidance for drugs that are intended for use in countries outside the European Union. Fexinidazole was approved for use in the Democratic Republic of the Congo.